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<section article="ghg" article_name="Health - General" number="21-220" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="2" subtitle_name="Maryland Food, Drug, and Cosmetic Act">
  <level label="a">
    <text>A drug that is intended for use by human beings and is in any of the following classifications may be dispensed by a pharmacist only on a written prescription, an electronic prescription, as defined in § 5–101 of the Criminal Law Article, or an oral prescription from a health practitioner authorized by law to prescribe the drug:</text>
    <level label="1">
      <text>A habit–forming drug to which § 21–218(b)(1) of this subtitle applies.</text>
    </level>
    <level label="2">
      <text>A drug that because of its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a health practitioner who is authorized by law to administer such a drug.</text>
    </level>
    <level label="3">
      <text>A drug that is limited by an approved application under § 355 of the federal act or § 21–223 of this subtitle to use under the professional supervision of a health practitioner authorized by law to administer such a drug.</text>
    </level>
  </level>
  <level label="b">
    <level label="1">
      <text>Subject to paragraph (2) of this subsection and subsection (c) of this section, a prescription may be written or oral or made through an electronic prescription.</text>
    </level>
    <level label="2">
      <text>A pharmacist may not dispense a drug on an oral prescription unless the pharmacist promptly writes out and files the prescription.</text>
    </level>
  </level>
  <level label="c">
    <level label="1">
      <text>Except as provided in paragraph (2) of this subsection, a health practitioner authorized by law to prescribe a controlled dangerous substance within the meaning of Title 5 of the Criminal Law Article shall issue a prescription for a controlled dangerous substance using an electronic prescription, as defined in § 5–101 of the Criminal Law Article.</text>
    </level>
    <level label="2">
      <text>A health practitioner may issue a written or, if authorized by State and federal law, oral prescription for a controlled dangerous substance only if:</text>
      <level label="i">
        <text>Electronic prescribing is not available due to temporary technological or electrical failure;</text>
      </level>
      <level label="ii">
        <text>The prescription is to be dispensed by a pharmacy located outside the State;</text>
      </level>
      <level label="iii">
        <text>The prescription is issued by a health practitioner outside the State;</text>
      </level>
      <level label="iv">
        <text>The health practitioner is prescribing and dispensing the controlled dangerous substance directly to the patient;</text>
      </level>
      <level label="v">
        <text>The prescription is being dispensed directly to the patient in accordance with § 12–102(c)(2)(iv) of the Health Occupations Article;</text>
      </level>
      <level label="vi">
        <text>The prescription is for an individual who:</text>
        <level label="1">
          <text>Resides in a nursing or assisted living facility;</text>
        </level>
        <level label="2">
          <text>Is receiving care through a hospice or palliative care program and the prescription is related to the care provided;</text>
        </level>
        <level label="3">
          <text>Is receiving care at an outpatient renal dialysis facility and the prescription is related to the care provided; or</text>
        </level>
        <level label="4">
          <text>Is detained or confined in a correctional facility, as defined in § 1–101 of the Correctional Services Article;</text>
        </level>
      </level>
      <level label="vii">
        <text>The prescription is issued by a licensed veterinarian;</text>
      </level>
      <level label="viii">
        <text>The prescription includes elements that are not supported by the most recent version of the National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard;</text>
      </level>
      <level label="ix">
        <text>The prescription is issued for a drug for which the federal Food and Drug Administration requires the prescription to contain certain elements that cannot be transmitted electronically;</text>
      </level>
      <level label="x">
        <text>The prescription prescribes a drug under a research protocol;</text>
      </level>
      <level label="xi">
        <text>The prescription is issued by a health practitioner who has received a waiver under subsection (d)(1) of this section;</text>
      </level>
      <level label="xii">
        <text>The prescription is issued by a health practitioner who requested a waiver under subsection (d)(1) of this section and the Department has not issued a waiver to the practitioner or has not rejected the practitioner’s request for a waiver;</text>
      </level>
      <level label="xiii">
        <text>The health practitioner issuing the prescription or the drug for which the prescription is issued falls under a waiver issued by the Secretary under subsection (d)(2) of this section;</text>
      </level>
      <level label="xiv">
        <text>The prescription is issued by a health practitioner who writes a low volume of prescriptions for controlled dangerous substances, as determined by the Maryland Health Care Commission; or</text>
      </level>
      <level label="xv">
        <text>The prescription is issued by a health practitioner under circumstances in which, although the practitioner has the ability to issue an electronic prescription as required by paragraph (1) of this subsection, the health practitioner reasonably determines that:</text>
        <level label="1">
          <text>It would be impracticable for the practitioner to prescribe the drug or device by electronic prescription in a timely manner; and</text>
        </level>
        <level label="2">
          <text>The delay would adversely impact the patient’s medical condition.</text>
        </level>
      </level>
    </level>
    <level label="3">
      <text>This subsection may not be construed to limit the right of a patient to designate a specific pharmacy to dispense a prescribed drug or device to the individual.</text>
    </level>
  </level>
  <level label="d">
    <level label="1">
      <text>The Secretary shall adopt regulations, in collaboration with the Maryland Health Care Commission, to establish a process for the Department to issue a waiver from the electronic prescription requirements in subsection (c)(1) of this section.</text>
    </level>
    <level label="2">
      <level label="i">
        <text>The Secretary may issue a waiver that applies generally to a group of health practitioners or drugs that meet conditions specified by the Secretary.</text>
      </level>
      <level label="ii">
        <text>Any waiver issued under subparagraph (i) of this paragraph for a group of health practitioners shall apply to a health practitioner in that group without requiring the health practitioner to go through the process established in regulations under paragraph (1) of this subsection.</text>
      </level>
    </level>
    <level label="3">
      <text>Except for a waiver issued under paragraph (2) of this subsection, the regulations adopted under paragraph (1) of this subsection shall specify that a waiver:</text>
      <level label="i">
        <text>May not exceed 1 year; and</text>
      </level>
      <level label="ii">
        <text>May be granted for the following reasons:</text>
        <level label="1">
          <text>Economic hardship;</text>
        </level>
        <level label="2">
          <text>Technological limitations that are not reasonably within the control of the health practitioner; or</text>
        </level>
        <level label="3">
          <text>Any other exceptional circumstances as demonstrated by the health practitioner.</text>
        </level>
      </level>
    </level>
    <level label="4">
      <text>The Secretary may adopt regulations on:</text>
      <level label="i">
        <text>Which temporary technological or electrical failures constitute an exception to the requirement to issue an electronic prescription under subsection (c)(1) of this section; and</text>
      </level>
      <level label="ii">
        <text>The circumstances under which a health practitioner is exempt from the requirement to issue an electronic prescription under subsection (c)(1) of this section because the prescription will be dispensed by a pharmacy located outside the State.</text>
      </level>
    </level>
  </level>
  <level label="e">
    <text>The appropriate health occupations board established under the Health Occupations Article may take disciplinary action against a health practitioner who violates subsection (c) of this section.</text>
  </level>
  <level label="f">
    <level label="1">
      <text>A pharmacist may dispense a drug on a written or oral prescription for a controlled dangerous substance that meets the requirements of this section.</text>
    </level>
    <level label="2">
      <text>A pharmacist who receives a written or oral prescription is not required to verify that the prescription is an authorized exception to the electronic prescription requirement under subsection (c)(2) of this section.</text>
    </level>
  </level>
  <level label="g">
    <level label="1">
      <text>If a prescription for a controlled dangerous substance within the meaning of Title 5 of the Criminal Law Article is written, it may not be written on a preprinted prescription form that states the name, quantity, or strength of the controlled dangerous substance.</text>
    </level>
    <level label="2">
      <text>When a prescription is written, a separate prescription form is required for each controlled dangerous substance. If a pharmacist is otherwise satisfied that a prescription is valid the pharmacist may fill the prescription if the pharmacist promptly writes out and files a prescription for each substance and also files the original prescription.</text>
    </level>
    <level label="3">
      <text>A written prescription shall be legible.</text>
    </level>
  </level>
  <level label="h">
    <text>A pharmacist may not refill and dispense a prescription unless the refilling is authorized by:</text>
    <level label="1">
      <text>The health practitioner’s specification in the original prescription as to how many times it may be refilled; or</text>
    </level>
    <level label="2">
      <text>An oral order of the health practitioner that promptly is written out and filed by the pharmacist.</text>
    </level>
  </level>
  <level label="i">
    <text>The dispensing of a drug without complying with the requirements of this section is the dispensing of a misbranded drug.</text>
  </level>
  <level label="j">
    <level label="1">
      <text>A drug that is subject to the prescription requirements of this section is misbranded if, at any time before it is dispensed, its label does not bear the statement “Caution: Federal Law Prohibits Dispensing Without Prescription”, or “Caution: State Law Prohibits Dispensing Without Prescription”.</text>
    </level>
    <level label="2">
      <text>A drug to which the prescription requirements of this section do not apply is misbranded if, at any time before it is dispensed, its label bears the caution statement quoted in paragraph (1) of this subsection.</text>
    </level>
  </level>
  <level label="k">
    <level label="1">
      <text>The prescription requirements of this section do not apply to any drug that is exempted under a rule or regulation adopted by the Secretary.</text>
    </level>
    <level label="2">
      <text>The Secretary, by rule or regulation, may exempt any drug from the requirements of this section if the Secretary finds that, as to the drug, the requirements of this section are not necessary for the protection of the public health.</text>
    </level>
    <level label="3">
      <text>The Secretary, by rule and regulation, may exempt from the requirements of this section any drug that is removed from the prescription requirements of the federal act by a rule or regulation adopted under that act.</text>
    </level>
  </level>
</section>
